This report is based on the findings from our seventh annual regulation survey, which was carried out in April to May 2022. Our regulation survey explores NHS trusts' and foundation trusts' experiences of regulation over the previous 12 months. This year's survey captures a unique moment in time, as trust leaders took stock of the COVID-19 pandemic and unprecedented operational pressures, while looking to a future of transformation across the health and care landscape, as ICSs were placed on a statutory footing.

In April 2022 the Health and Care Act received royal assent, formalising the biggest legislative change in the NHS in a decade. The Act puts ICSs and the Health Services Safety Investigations Body (HSSIB) on a statutory footing and formalises the merger of NHS Improvement with NHS England. In addition to these structural reforms, it builds on the ambitions set out in the NHS Long Term Plan, emphasising prevention, integration of services, and reducing health inequalities. Importantly, the new legislation gives CQC a formal role in relation to systems. As a result, the regulator will now be reviewing and assessing ICSs, as well as local authorities with regard to their duties in adult social care.

Reflecting this new set of structures and priorities, the key regulatory bodies for trusts – CQC and NHS England – have also signalled a clear shift in their approaches to regulation and oversight.

The regulatory context

Care Quality Commission

In April 2021 CQC published its new strategy, signalling a move to a "smarter", more dynamic and flexible style of regulation, driven by the needs of people and communities and focused on learning and improvement. The aim of the strategy is to modernise and streamline CQC's regulatory approach, but also to make it relevant to the new system context.

As we mention above, the new legislation has given CQC a formal role in relation to systems. As a result, the regulator will now be reviewing and assessing integrated care systems, as well as local authorities with regard to their duties in adult social care.

CQC is currently working with stakeholders to develop a new single assessment framework, which will apply across providers, systems and local authorities and will be operational from April 2023. It will be based on a set of quality statements, intended to reflect people's experiences and expectations of care, as well as on new evidence categories. It will introduce a more granular system of scoring and rating services, which will be regularly updated. The intention behind this is to provide a more nuanced and up-to-date picture of quality.


NHS England and NHS Improvement (NHS England)

In June 2021 NHSE/I published its system oversight framework (SOF) for 2021/22, which also reflected the shift towards system working. The framework applied to providers, commissioners and integrated care systems alike. It set expectations of how these partners should work together to deliver care, and explained how NHSE/I would monitor performance. The SOF introduced new oversight metrics, as well as a new recovery support programme (RSP) for poorly performing providers, commissioners and systems, which replaced the previous quality and finance 'special measures' regime.

In late June 2022, NHSE/I published a refreshed version of the SOF for 2022/23, to bring the 2021/22 framework up to date for the official launch date of ICSs on 1 July 2022. Our survey, however, explored trusts' experiences and views of the SOF for 2021/22, which they have been using since November 2021.

The regulator has been hearing feedback around the SOF's application, the clarity of roles and functions between NHSE/I and ICSs, as well as the validity and durability of its metrics. Such feedback will hopefully inform the next iteration of the SOF for 2023/24, to be published by the newly merged NHS England, which will be subject to a full review and consultation later this year.

The provider context 

In the midst of these changes to the statutory framework, during 2021/22 the provider sector has faced a challenging operational task encompassing the ongoing COVID-19 pandemic, and its legacy in the form of unprecedented pressure on urgent and emergency care, alongside care backlogs, growing elective care waiting lists, and increasing demand for community and mental health services. This has been compounded by ongoing staff shortages, along with capacity shortages in social care.

This report highlights the importance of ensuring regulation is sensitive to the pressures that providers are facing and avoids placing an unnecessary additional burden on them. It reflects the need for regulation that adapts quickly in response to changes in the external environment, remaining proportionate, coordinated and easy to navigate – trusts value regulators who act as a partner able to provide a reality check and a trigger for improvement.

We are grateful to all trust leaders who responded to our survey and whose views are reflected in this report. We are also grateful to CQC and NHSE/I who advised on some of our questions and have been working with us and our members in refining their regulatory approaches.